Search by Drug Name or NDC

NDC 10129-0038-03 Perio Armor-X 1.7 g/100g Details

Perio Armor-X 1.7 g/100g

Perio Armor-X is a DENTAL; PERIODONTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gingi-Pak a Division of the Belport. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	10129-0038
Product ID	10129-038_e77bc6e7-de68-3e91-e053-2a95a90a96b2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Perio Armor-X
Proprietary Name Suffix	n/a
Non-Proprietary Name	1.7% Hydrogen Peroxide
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	DENTAL; PERIODONTAL
Active Ingredient Strength	1.7
Active Ingredient Units	g/100g
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Gingi-Pak a Division of the Belport
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 10129-0038-03 (10129003803)

Pricing Information	N/A
NDC Package Code	10129-038-03
Billing NDC	10129003803
Package	1 TUBE in 1 BOX (10129-038-03) / 86 g in 1 TUBE
Marketing Start Date	2022-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e77bc6e7-de67-3e91-e053-2a95a90a96b2 Details

Active Ingredients

Hydrogen Peroxide 1.7% (w/w)

Purpose

Wound Cleanser

Indication and Uses

For temporary use in cleansing minor oral wounds and treatment of inflammation resulting from dental procedures or other irritations of the mouth and gums. Perio Armor may be used for decreasing the presence of plaque, a known factor in the development of gingivitis and tooth decay.

Directions

For children under 2 years of age, consult a dentist or physician before use. For adults and children 2 years of age or older: 1. Remove cap and cut the tip of the tube at the narrow end. 2. Apply several drops of the gel directly onto the affected area in the mouth. 3. Leave the gel on the affected area for at least 60 seconds, then spit. 4. Use up to 4 times daily after meals, at bedtime, or as directed by a dentist or physician.

Other Information

Store at room temperature between 20-25° C (68-77° F) and away from direct sunlight. Do not use if the tube has been damaged or tampered in any way.

Inactive Ingredients

Ethyl Alcohol, Menthol, Methyl Salicylate, Phosphoric Acid, Poloxamer 407, Polysorbate 20, Potassium Sorbate, Xylitol, Sorbitol, Water

Question or Comments?

(800)437-1514 or www.gingi-pak.com.

Warnings

Do not use Perio Armor-X for more than 7 days unless directed by your dentist or physician.

Stop use and consult your dentist or physician if: • Symptoms do not improve within 7 days • Irritation, pain, or redness persists or worsens • Swelling, rash, or fever develops

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERIO ARMOR-X

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-039
Route of Administration	PERIODONTAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-039-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022

PERIO ARMOR-X

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-038
Route of Administration	PERIODONTAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-038-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022

PERIO ARMOR-X

1.7% hydrogen peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10129-042
Route of Administration	PERIODONTAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	1.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
XYLITOL (UNII: VCQ006KQ1E)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SORBITOL (UNII: 506T60A25R)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10129-042-03	1 in 1 BOX	08/15/2022
1		86 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/2022

Labeler - Gingi-Pak a Division of the Belport (008480121)

Registrant - Jeff Nichols (008480121)

Name	Address	ID/FEI	Business Operations
Establishment
Gingi-Pak a Division of the Belport		008480121	manufacture(10129-038, 10129-039, 10129-042)

Revised: 8/2022

Document Id: e77bc6e7-de68-3e91-e053-2a95a90a96b2

Set id: e77bc6e7-de67-3e91-e053-2a95a90a96b2

Version: 1

Effective Time: 20220830

Search by Drug Name or NDC

NDC 10129-0038-03 Perio Armor-X 1.7 g/100g Details

Perio Armor-X 1.7 g/100g

Product Information

Package

Package Images

NDC 10129-0038-03 (10129003803)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e77bc6e7-de67-3e91-e053-2a95a90a96b2 Details

Active Ingredients

Purpose

Indication and Uses

Directions

Other Information

Inactive Ingredients

Question or Comments?

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

Can You Take A Z-Pak If You Have A Penicillin Allergy?